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Completed

NCT Number: NCT06027593

Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions

The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for:

1) adult inpatients with community-acquired pneumonia; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.

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Key information

Conditions

Community-Acquired Pneumonia Acute Otitis Media Community-Acquired Infections Ear Diseases Infections Otitis Otitis Media Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

Antibiotic stewardship has been shown to improve patient outcomes, decrease adverse events, and decrease antibiotic resistance. This group of investigators previously partnered with collaborators at the Centers for Disease Control and Prevention and conducted relevant pilot work in developing and validating electronic indicators of inappropriate antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in this study: adult inpatients with community-acquired pneumonia; pediatric inpatients with community-acquired pneumonia; adult outpatients with acute pharyngitis; and pediatric outpatients with acute otitis media. Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy (pharyngitis and acute otitis media only); 2) the choice of antibiotic agent; and 3) the duration of antibiotic use.

The purpose of this project is to assess the impact of these developed electronic indicators on supporting antibiotic stewardship efforts to improve the appropriateness of antibiotic use, as well as the acceptability and feasibility of delivering these reports to prescribers. The investigators aim to:

  • Refine and validate indicators of appropriate antibiotic use by utilizing Electronic Health Record data, including International Classification of Diseases version 10 codes, medications, laboratory data, co-morbid medical conditions, site of care, clinical documentation, prior hospitalizations, and medication exposure. The researchers will validate the definitions of the various conditions and appropriateness captured electronically with a manual chart review of clinical documentation.
  • Implement a scalable and sustainable antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
  • Track the impact of the stewardship interventions and report to key stakeholders, including prescribers.
  • Create a publicly available toolkit based on the findings of this project that includes: (i) analytic tools and resources for using the automated reports of key indicators to target stewardship interventions and (ii) an implementation guide to inform the application of automated reports to stewardship in the inpatient and outpatient settings.

If proven effective, these electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • Diagnosis of one of four conditions based on ICD-10 diagnostic codes.

Patient Exclusion Criteria:

  • Presence of specific complex chronic conditions
  • Use of immunocompromising medications
  • Transfer from another health facility.

Clinician Inclusion Criteria:

  • Prescribing clinicians (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) at one of the participating outpatient practices or inpatient units.
  • Age ≥ 18 years old
  • Employed by one of the participating sites

Clinician Exclusion Criteria:

  • Volunteers or other non-employee hospital staff
  • Limited English proficiency

Treatment and study plan

Quasi experimental intervention

Other

The intervention included clinician education and sharing of audit and feedback reports summarizing antibiotic use metrics for each of the four target conditions with treating clinicians.

Primary outcomes

  1. Guideline-concordant Antibiotic Use for Adults With Pharyngitis

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  2. Guideline-concordant Antibiotic Use for Children With Acute Otitis Media

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  3. Guideline-concordant Antibiotic Use for Adults With Community-acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  4. Guideline-concordant Antibiotic Use for Children With Community-acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

Secondary outcomes

  1. Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic choice. The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  2. Guideline-concordant Antibiotic Duration for Adults Hospitalized With Community Acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic duration. The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  3. 30-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults

    Time frame: 30 days

    Count of participants with community-acquired pneumonia with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for community acquired pneumonia within 30 days of discharge following index hospitalization for adult community acquired pneumonia. The count of participants with community-acquired pneumonia with a return visit in the outpatient setting was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with a return visit in the outpatient setting.

  4. 30-day Readmissions for Community Acquired Pneumonia in Adults

    Time frame: 30 days

    Count of participants with a readmission for community-acquired pneumonia within 30 days of discharge following an index hospitalization for community-acquired pneumonia. The count of participants with a readmission for community-acquired pneumonia was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with readmissions within 30 days of discharge following an index hospitalization for community-acquired pneumonia.

  5. Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  6. Guideline-concordant Antibiotic Duration for Pediatric Community Acquired Pneumonia

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  7. 28-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Children

    Time frame: 28 days

    Count of participants with pediatric community-acquired pneumonia with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pediatric community acquired pneumonia within 28 days of discharge following index hospitalization for pediatric community acquired pneumonia. The count of participants with pediatric community-acquired pneumonia with a return visit in the outpatient setting was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants with a return visit in the outpatient setting.

  8. 28-day Readmissions for Pediatric Community Acquired Pneumonia

    Time frame: 28 days

    Count of participants with a readmission for community-acquired pneumonia within 28 days of discharge following an index hospitalization for community-acquired pneumonia. The count of participants with a readmission for community-acquired pneumonia was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with readmissions within 28 days of discharge following an index hospitalization for community-acquired pneumonia.

  9. Guideline-concordant Decision to Prescribe Antibiotics for Adult Pharyngitis

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pharyngitis for which the decision to prescribe an antibiotic was correct. The count of participants with pharyngitis for which the decision to prescribe an antibiotic was correct was divided by the total number of participants with pharyngitis to generate the percentage of participants for which the decision to prescribe an antibiotic was correct. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  10. Guideline-concordant Antibiotic Choice Adult Pharyngitis

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with adult pharyngitis with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pharyngitis with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  11. Guideline-concordant Antibiotic Duration for Adult Pharyngitis

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with adult pharyngitis with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pharyngitis with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  12. 30-day Pharyngitis Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults

    Time frame: 30 days

    Count of participants with adult pharyngitis with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pharyngitis within 30 days of discharge following index hospitalization for adult pharyngitis. The count of participants with pharyngitis with a return visit in the outpatient setting was divided by the total number of participants with pharyngitis to generate the percentage of participants with a return visit in the outpatient setting.

  13. 30-day Deep Neck Space Infection Admission

    Time frame: 30 days

    Count of participants with a readmission for deep neck space infection within 30 days of index encounter for pharyngitis. The count of participants with a readmission for deep neck space infection was divided by the total number of participants with adult pharyngitis to generate the percentage of participants with readmissions for deep neck space infection within 30 days of index encounter for pharyngitis.

  14. Guideline-concordant Decision to Prescribe Antibiotics for Pediatric Acute Otitis Media

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric acute otitis media for which the decision to prescribe an antibiotic was correct. The count of participants with pediatric acute otitis media for which the decision to prescribe an antibiotic was correct was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants for which the decision to prescribe an antibiotic was correct. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  15. Guideline-concordant Antibiotic Choice for Pediatric Acute Otitis Media

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pediatric acute otitis media visits with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  16. Guideline-concordant Antibiotic Duration for Pediatric Acute Otitis Media

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  17. 28-day Acute Otitis Media-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care)

    Time frame: 28 days

    Count of participants with pediatric acute otitis media with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pediatric acute otitis media within 28 days of the index acute otitis media encounter. The count of participants with pediatric acute otitis media with a return visit in the outpatient setting was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants with a return visit in the outpatient setting.

  18. 28-day Mastoiditis or Intracranial Infection Admissions

    Time frame: 28 days

    Count of participants with a readmission for mastoiditis or intracranial infection within 28 days of the index encounter for pediatric acute otitis media. The count of participants with a readmission for mastoiditis or intracranial infection was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants with readmissions within 28 days of discharge following an index hospitalization for acute otitis media.

  19. Guideline-concordant Decision to Not Prescribe Antibiotics for Pediatric Acute Otitis Media

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for appropriate decision not to prescribe antibiotics. The count of participants with pediatric acute otitis media with an appropriate decision not to prescribe antibiotics was divided by the total number of participants with no antibiotics prescribed to generate the percentage of participants appropriately not prescribed antibiotics for acute otitis media. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

  20. Guideline-concordant Decision to Not Prescribe Antibiotics for Adult Pharyngitis

    Time frame: Pre-intervention and post-intervention, up to 2 years

    Count of participants with adult pharyngitis with guideline-concordant antibiotic use for appropriate decision not to prescribe antibiotics. The count of participants with adult pharyngitis with an appropriate decision not to prescribe antibiotics was divided by the total number of participants with no antibiotics prescribed to generate the percentage of participants appropriately not prescribed antibiotics for pharyngitis. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.

Other outcomes

  1. Feasibility of Intervention - Outpatient

    Time frame: One time measure in the post intervention time period

    Feasibility is defined as the extent to which the intervention can be carried out in the clinical setting. The feasibility of intervention measure is the full name of this scale. The feasibility of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more feasible. There are no validated cutoffs for feasibility. The mean total score and standard deviation of the mean total score for all respondents are reported. The feasibility of intervention measure was assessed by a one time survey in the post-intervention time period.

  2. Acceptability of Intervention - Outpatient

    Time frame: One time measure in the post intervention time period

    Acceptability is defined as how well the intervention was received by the prescribing clinicians. The acceptability of intervention measure is the full name of this scale. The acceptability of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more acceptable. There are no validated cutoffs for acceptability. The mean total score and standard deviation of the mean total score for all respondents are reported. The acceptability of intervention measure was assessed by a one time survey in the post-intervention time period.

  3. Feasibility of Intervention Measure - Inpatient

    Time frame: One time measure in the post intervention time period

    Feasibility is defined as the extent to which the intervention can be carried out in the clinical setting. The feasibility of intervention measure is the full name of this scale. The feasibility of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more feasible. There are no validated cutoffs for feasibility. The mean total score and standard deviation of the mean total score for all respondents are reported. The feasibility of intervention measure was assessed by a one time survey in the post-intervention time period.

  4. Acceptability of Intervention Measure - Inpatient

    Time frame: One time measure in the post intervention time period.

    Acceptability is defined as how well the intervention was received by the prescribing clinicians. The acceptability of intervention measure is the full name of this scale. The acceptability of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more acceptable. There are no validated cutoffs for acceptability. The mean total score and standard deviation of the mean total score for all respondents are reported. The acceptability of intervention measure was assessed by a one time survey in the post-intervention time period.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of Pennsylvania

Registry information

Acronym: EMPOWER

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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